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Mark Brager
June 13, 2013

AdvaMed Statement on Medical Devices and Cybersecurity

WASHINGTON, D.C. – Janet Trunzo, senior executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement in response to FDA’s release today of a safety communication and guidance on cybersecurity and medical devices:

“Despite the fact that there has been no patient harm as the result of either inadvertent or intentional cyber security breaches, we understand FDA's desire to be cautious in this area.  Our industry provides many life-saving or life-enhancing devices.  So, it is important for both the manufacturers and the users of these devices to be aware of the potential for cybersecurity breaches.

“Patient safety is the number one priority of the medical technology industry, and manufacturers have in place numerous safeguards to ensure the security and integrity of their devices.  The ubiquity of digital technologies offers patients significant benefits, and the risk of a malicious cyber-attack is low when compared to these benefits.  At the same time, manufacturers recognize the need for increased security with these devices.

“All manufacturers of electronic medical devices, as part of the work they do for product development and product approval, maintain a risk management system in which they evaluate potential events that could harm a patient and the probability of those events taking place.

“Medical technology companies have taken steps to further reduce the already low risk of malicious hacking and to ensure patient safety, including:

  • Building device security into new product development processes;
  • Continual vulnerability testing and remediation; and
  • Ongoing risk assessments.

“The medical technology industry looks forward to working with FDA, health care providers, the academic community, security experts and other stakeholders on potential ways to continue to ensure the safety and effectiveness of digitally-controlled medical devices.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments.  AdvaMed members range from the largest to the smallest medical technology innovators and companies.